MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-23 for N/A 305115 manufactured by Becton, Dickinson And Company.
[184450567]
Nurse administered subcutaneous medication and re-capped the needle utilizing the scoop method. The nurse then proceeded to push on the needle cap to firmly secure it to the needle hub and did not realize that the needle had penetrated the cap, which resulted in a needle stick to the nurse.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9864758 |
| MDR Report Key | 9864758 |
| Date Received | 2020-03-23 |
| Date of Report | 2020-02-19 |
| Date of Event | 2020-01-27 |
| Report Date | 2020-02-19 |
| Date Reported to FDA | 2020-02-19 |
| Date Reported to Mfgr | 2020-03-23 |
| Date Added to Maude | 2020-03-23 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | N/A |
| Generic Name | NEEDLE, HYPODERMIC, SINGLE LUMEN |
| Product Code | FMI |
| Date Received | 2020-03-23 |
| Model Number | 305115 |
| Catalog Number | 305115 |
| Lot Number | 7285614 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON, DICKINSON AND COMPANY |
| Manufacturer Address | 1 BECTON DRIVE FRANKLIN LAKES NJ 07417 US 07417 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-23 |